The palate forms the arched roof of the mouth and the floor of the nasal cavities. The hard palate is a concave structure whose anterior two-thirds has a skeleton formed by the palatine processes of the maxillary and the horizontal plates of the palatine bones. A common congenital deformity is cleft palate, in which the maxillary segments of the palate do not fuse properly during embryonic and fetal development. The cleft may involve only the uvula, or may extend through the soft and hard regions of the palate, and may also include a cleft of the gum and the lip. This invention pertains to, inter alia, the treatment of wide cleft lip and palate. A cleft palate may be unilateral complete, unilateral incomplete, bilateral complete, bilateral incomplete, or mid-line. The embryological basis of cleft palate is failure of the mesenchymal masses in the lateral palatine processes to meet and fuse with each other, with the nasal septum, or with the posterior margin of the median palatine process.
An estimated 7,500 children are born in the United States each year with cleft lip, cleft palate, or both. In addition to having a facial disfigurement, children with cleft palate may also suffer from eating, speaking, or hearing abnormalities. Pre-surgical orthopedic treatment of cleft palate malformations reduces the distance between the maxillary segments. This treatment facilitates subsequent soft-tissue repair, as, for example, the lip repair will be under less tension than it would have been without treatment. One existing method of pre-surgical treatment uses the Latham dentomaxillary appliance (DMA), which is pinned to the subject's palatal bone segments while the subject is under general anesthesia. The DMA appliance is adjusted daily. Another method uses the naso-alveolar molding (NAM) device (by Grayson and Cutting), in which a removable acrylic plate is modified manually by orthodontists at weekly intervals.